Type 2 DiabetesCACAOBANCT04383639
Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes
A study testing No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C) in people with Type 2 Diabetes, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes during the last 2 years and current treatment with metformin
- Overweight or obesity (IMC = 26-40 kg/m2)
Who cannot join
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 125 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers currently participating in other studies or weight loss plans.
- Pregnant or breastfeeding women.
- Adherence to vegetarian diets or usual consumption of dietary supplements.
- Intolerance or allergy to some of the foods provided in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Madrid, 28040
About this study
Official title: Evaluation of Postprandial Effects of High Molecular Weight Polyphenols in Subjects With Type 2 Diabetes
The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects with type 2 diabetes. Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used food extracts, ignoring high molecular weight polyphenols as relevant bioactive compounds. In this study, the potential of this kind of polyphenols for regulating postprandial disturbances in type 2 diabetes subjects, since these alterations increased the cardiovascular risk in these subjects, will be evaluated. The study has been designed in order to differentially evaluate the effect of intact polyphenols and that of microbial-derived phenolic metabolites.
Read the detailed description
Twenty-five subjects with a recent diagnosis of type 2 diabetes will be recruited. Detailed inclusion and exclusion criteria are provided below.
The whole intervention has been divided in 3 treatments A, B and C, performed every 2 weeks in randomized order for each subject. In every treatment, subjects will attend to the Unit of Human Nutrition of the ICTAN-CSIC in fasting state and they will receive a high-sugar high-fat breakfast. Treatment A will be used as control and will only consist of breakfast. Treatment B is characterized by the administration of a mixture of cocoa and carob solved in milk together with breakfast. In treatment C, volunteers will consume the same amount of product 10 hours before attending to their visit, where the breakfast will be administrated once again. Food and drinks provided in the three visits (including milk used in treatment B) will be similar. The aim of treatment B is to elucidate the role of intact polyphenols, while treatment C will evaluate the effect of microbial-derived polyphenol metabolites.
Blood samples will be collected before breakfast and at times 60-120-180-240-270 min. Urine will be collected during their permanence at the Unit of Human nutrition of the ICTAN-CSIC. Feces will be collected as soon as they are generated after receiving treatments A and C. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, GLP-1, hepatic enzymes. Urine and feces will be used to evaluate phenolic metabolites. Additionally, a satiety test will be provided. It is expected that cocoa and carob supplementation, as compared to the control treatment, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the decrease in postprandial insulin.
- Conditions
- Type 2 Diabetes
- Being tested
- No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)
- Keywords
- Polyphenols, Type 2 diabetes, Cocoa, Carob, Postprandial response, Insulin resistance, Microbial metabolites
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)Other
The subjects will receive, after overnight fasting, a high-fat high-sugar breakfast. In treatment A, they will not receive any additional product; in treatment B, they will receive at the same time a mixture of coca and carob; in treatment C, they will receive the mixture of coca and carob 10 h before breakfast. A total of 6 blood samples will be collected during each visit: 0-30-60-120-180-240-270 min. Urine samples will be collected during the permanence of the subjects in the Unit of Human Nutrition. Feces will be collected the first time they are generated after treatments A and C. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). Receives: Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C) |
| 2 | Experimental | All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). Receives: Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C) |
| 3 | Experimental | All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). Receives: Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial insulin
Changes of postprandial insulin as result of supplementation with cocoa and carob
Measured: Up to two months
Secondary outcomes (6)
Postprandial glucose
Changes of blood glucose as result of supplementation with cocoa and carob.
Measured: Up to four months
Postprandial triglycerides
Changes of blood triglycerides as result of supplementation with cocoa and carob.
Measured: Up to four months
Postprandial uric acid
Changes of blood uric acid as result of supplementation with cocoa and carob.
Measured: Up to four months
Postprandial GLP-1
Changes of blood GLP-1 as result of supplementation with cocoa and carob.
Measured: Up to five months
Postprandial phenolic metabolites
Changes of urinary and fecal phenolic metabolites as result of supplementation with cocoa and carob.
Measured: Up to six months
Satiety measured by a Visual Analogue Scale (see "Description" for details)
Changes of satiety as result of supplementation with cocoa and carob. This will be determined by the CSS, composite satiety score. This is a value obtained from a formula once the subject has filled in, in a visual analogue scale, the answer to different questions regarding hunger and satiety. The answers go from 1 to 10 (each mark corresponding to a similar distance in the scale). The final CSS value goes also from 1 to 10, with 1 meaning the lowest satiety and 10 meaning the highest one.
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start3 May 2021
- Primary completion28 Feb 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A: control period; B: mixture of cocoa and carob consumed together with breakfast; C: mixture of cocoa and carob consumed 10 h before breakfast. All the subjects will pass the three treatments, in randomized order. The three periods will be separated by a two weeks washing period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Jara Pérez-Jiménez, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383639
- Sponsor's protocol ID
- RTI2018DIABE
- Acronym
- CACAOBA
- Status last verified
- Nov 2023
- First submitted
- 6 May 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postprandial Effects of High Molecular Weight Polyphenols in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04383639
- Acronym / sponsor ID
- CACAOBA / RTI2018DIABE
- Conditions
- Type 2 Diabetes
- Keywords
- Polyphenols, Type 2 diabetes, Cocoa, Carob, Postprandial response, Insulin resistance, Microbial metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 3 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects with type 2 diabetes. Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used food extracts, ignoring high molecular weight polyphenols as relevant bioactive compounds. In this study, the potential of this kind of polyphenols for regulating postprandial disturbances in type 2 diabetes subjects, since these alterations increased the cardiovascular risk in these subjects, will be evaluated. The study has been designed in order to differentially evaluate the effect of intact polyphenols and that of microbial-derived phenolic metabolites.
Detailed description
Twenty-five subjects with a recent diagnosis of type 2 diabetes will be recruited. Detailed inclusion and exclusion criteria are provided below.
The whole intervention has been divided in 3 treatments A, B and C, performed every 2 weeks in randomized order for each subject. In every treatment, subjects will attend to the Unit of Human Nutrition of the ICTAN-CSIC in fasting state and they will receive a high-sugar high-fat breakfast. Treatment A will be used as control and will only consist of breakfast. Treatment B is characterized by the administration of a mixture of cocoa and carob solved in milk together with breakfast. In treatment C, volunteers will consume the same amount of product 10 hours before attending to their visit, where the breakfast will be administrated once again. Food and drinks provided in the three visits (including milk used in treatment B) will be similar. The aim of treatment B is to elucidate the role of intact polyphenols, while treatment C will evaluate the effect of microbial-derived polyphenol metabolites.
Blood samples will be collected before breakfast and at times 60-120-180-240-270 min. Urine will be collected during their permanence at the Unit of Human nutrition of the ICTAN-CSIC. Feces will be collected as soon as they are generated after receiving treatments A and C. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, GLP-1, hepatic enzymes. Urine and feces will be used to evaluate phenolic metabolites. Additionally, a satiety test will be provided. It is expected that cocoa and carob supplementation, as compared to the control treatment, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the decrease in postprandial insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A: control period; B: mixture of cocoa and carob consumed together with breakfast; C: mixture of cocoa and carob consumed 10 h before breakfast. All the subjects will pass the three treatments, in randomized order. The three periods will be separated by a two weeks washing period.
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). |
| 2 | Experimental | Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). |
| 3 | Experimental | Other: No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)All subjects will receive a high-fat high-sugar breakfast in three different days. They will not consume any additional product (1), they will receive the mixture of coca and carob together with breakfast (2) or they will receive the mixture of coca and carob 10 h before breakfast (3). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes during the last 2 years and current treatment with metformin
- Overweight or obesity (IMC = 26-40 kg/m2)
Key exclusion criteria (8 listed)
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 125 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers currently participating in other studies or weight loss plans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)The subjects will receive, after overnight fasting, a high-fat high-sugar breakfast. In treatment A, they will not receive any additional product; in treatment B, they will receive at the same time a mixture of coca and carob; in treatment C, they will receive the mixture of coca and carob 10 h before breakfast. A total of 6 blood samples will be collected during each visit: 0-30-60-120-180-240-270 min. Urine samples will be collected during the permanence of the subjects in the Unit of Human Nutrition. Feces will be collected the first time they are generated after treatments A and C. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided). | Other | 1, 2, 3 |
Primary outcome
Postprandial insulin
Time frame: Up to two months
Changes of postprandial insulin as result of supplementation with cocoa and carob
6 secondary outcomes
Postprandial glucose
Time frame: Up to four months
Postprandial triglycerides
Time frame: Up to four months
Postprandial uric acid
Time frame: Up to four months
Postprandial GLP-1
Time frame: Up to five months
Postprandial phenolic metabolites
Time frame: Up to six months
Satiety measured by a Visual Analogue Scale (see "Description" for details)
Time frame: Up to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C) in people with Type 2 Diabetes, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial insulin (time frame: Up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.